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DSM Biomedical Calcium Phosphate Cement with Microspheres is indicated to fill bony voids or gaps of the sketal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement with Microspheres is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement with Microspheres cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement with Microsheres resorbs and is replaced by bone during the healing process.

DSM Biomedical Calcium Phosphate Cement with Microspheres is an injectable, fast self-setting bone substitute. DSM Biomedical Calcium Phosphate Cement with Microspheres is composed of calcium phosphate which converts to hydroxyapatite in vivo, bovine collagen powder, and PLGA microspheres. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form packaged in a mixing syringe. The mixing syringe allows for the combination of saline, the patient's blood, or the patient's bone marrow at the required powder-to-liquid ratio. DSM Biomedical Calcium Phosphate Cement with Microspheres is supplied sterile by gamma irradiation and is non-pyrogenic.

The provided text is a 510(k) Summary for the DSM Biomedical Calcium Phosphate Cement with Microspheres, describing its design, indications, and the basis for substantial equivalence to a predicate device. It details the tests performed to demonstrate safety and performance but does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria specifically in the context of an AI/ML device.

The document discusses material characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study for a medical device that fills bony voids. It compares the characteristics of the proposed device with a predicate device (Stryker® Injectable Cement).

Therefore, I cannot provide the requested information for an AI/ML device, as the provided text pertains to a traditional medical device (bone void filler) and does not mention any AI/ML components or related studies (like MRMC studies, standalone AI performance, or expert consensus for AI ground truth).

To answer your request, the input text would need to be a 510(k) summary for an AI/ML medical device.

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DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The DSM Biomedical Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The DSM Biomedical Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process.

DSM Biomedical Calcium Phosphate Cement as an injectable, fast self-setting bone substitute. DSM Biomedical Calcium Phosphate Cement is composed of calcium phosphate which converts to hydroxyapatite in vivo, and bovine collagen powder. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form packaged in a mixing syringe. The mixing syringe allows for the combination of saline, the patient's blood, or the patient's bone marrow at the required powder-to-liquid ratio. DSM Biomedical Calcium Phosphate Cement is supplied sterile by gamma irradiation and is non-pyrogenic.

The provided text is a 510(k) summary for the DSM Biomedical Calcium Phosphate Cement. It states that the device is substantially equivalent to a predicate device based on various criteria, including performance data. However, the document does not contain the level of detail requested in the prompt regarding acceptance criteria, specific reported device performance values, sample sizes for test or training sets, expert qualifications, or adjudication methods for studies.

The document primarily focuses on establishing substantial equivalence to a predicate device (Stryker® Injectable Cement K060061) through comparisons of:

• Indications for Use
• Material Composition
• Technological Characteristics
• Performance Characteristics

It mentions that "material characterization, including chemical and material physical characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study have been conducted to evaluate the performance characteristics and biological safety." It also states these were completed in accordance with FDA Guidance Document, "Resorbable Calcium Salt Bone Void Filler Device and ASTM F1185 Standard Specification for Composition of Hydroxylapatite for Surgical Implants."

An "ovine bilateral femoral defect animal study" was performed to evaluate bone healing.

Therefore, many of the specific details requested cannot be extracted from this document.

However, I can provide a summary of what is mentioned concerning performance and the basis for substantial equivalence:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with quantitative acceptance criteria and corresponding reported device performance values. It states that tests were conducted according to FDA guidance and ASTM standards, implying that the device met the requirements of those standards.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated for any of the tests.
• Data Provenance: The animal study was an "ovine bilateral femoral defect animal study." This suggests an animal model study, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as this is related to a medical image analysis or diagnostic device, which this bone void filler is not. The ground truth for performance would be based on the physical, chemical, and biological measurements from the lab and animal studies.

4. Adjudication method for the test set

Not applicable for this type of device and study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/imaging device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/imaging device.

7. The type of ground truth used

For the performance of the material:

• Physical and chemical characterization data (e.g., setting time, mechanical strength, composition, resorption rate – though specific values are not listed).
• Biocompatibility test results (cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, hemocompatibility, subacute toxicity, implantation).
• Viral inactivation study results.
• Residual chemical assessment results.
• Bone healing evaluation from the ovine animal study (comparison to predicate).

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/machine learning device.

Summary of Device Performance (as described in the document, without specific values):

The document concludes that "The bench, animal, and biocompatibility testing demonstrates that DSM Biomedical Calcium Phosphate Cement is substantially equivalent to the predicate device." This implies that the device met the performance requirements necessary to establish substantial equivalence based on the completed tests.

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DSM Biomedical Dental Bone Graft is indicated for:

• Augmentation or reconstructive treatment of the alveolar ridge
• Filling of infrabony periodontal defects
• Filling of defects after root resection, apicoectomy, and cystectomy
• Filling of extraction sockets to enhance preservation of the alveolar ridge
• Elevation of the maxillary sinus floor
• Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

The DSM Biomedical Dental Bone Graft is a non-pyrogenic porous bone mineral matrix for use in periodontal, oral, and maxillofacial surgery. It is produced by removing organic components from porcine bone. The composition of DSM Biomedical Dental Bone Graft meets the requirements of ASTM F 1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is provided as cancellous granules approximately 0.25 - 1.0mm in size. It is supplied sterile by gamma irradiation and is for single use only.

The provided text is a 510(k) summary for the DSM Biomedical Dental Bone Graft. It describes the device, its indications for use, and a comparison to a predicate device (Bio-OSS®). However, this document does not contain the acceptance criteria or a study proving that an AI device meets acceptance criteria.

Instead, it pertains to a traditional medical device (a dental bone graft material) and focuses on demonstrating substantial equivalence to a predicate device through material characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device's performance based on the provided text. The document does not describe an AI device.

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DSM Biomedical Porcine Pericardium Dental Membrane is indicated for:

• simultaneous use of GBR-membrane and implants
• augmentation around implants placed in immediate extraction sockets
• augmentation around implants placed in delayed extraction sockets
• localized ridge augmentation for later implantation
• alveolar ridge reconstruction for prosthetic treatment
• filling of bone defects after root resection, cystectomy, removal of retained teeth
• guided bone regeneration in dehiscence defects
• guided tissue regeneration procedures in periodontal defects.

The DSM Biomedical Porcine Pericardium Dental Membrane is a resorbable porcine pericardium derived extracellular matrix barrier membrane for guided tissue and bone regeneration in dental applications. The device is manufactured using a standardized, controlled, multistage process. The origin of all animals is the United States of America. It is provided as a lyophilized sheet in sizes 15 mm x 25 mm, 20 mm x 30 mm, and 30 mm x 40 mm, which may be hydrated with saline or blood. It can be easily trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane is easily drapeable while maintaining suture tear resistance. It is supplied sterile by ethylene oxide and is for single use only.

The DSM Biomedical Porcine Pericardium Dental Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. Animal studies have shown that DSM Biomedical Porcine Pericardium Dental Membrane is resorbed within 2 to 9 weeks.

This document is a 510(k) summary for the DSM Biomedical Porcine Pericardium Dental Membrane, seeking substantial equivalence to a predicate device (Bio-Gide® K042197).
The provided text does not contain detailed acceptance criteria or a study design in the format typically used for evaluating the performance of AI/ML-based medical devices (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating the substantial equivalence of a physical medical device (a resorbable membrane) to a predicate device.

However, I can extract the relevant information from the document to answer your questions based on the type of device and study described.

Here's the breakdown of the "acceptance criteria" and "study" as presented in this context:

1. A table of acceptance criteria and the reported device performance

In the context of this 510(k), "acceptance criteria" are not reported as specific numerical thresholds for diagnostic performance. Instead, the acceptance criteria are implicitly that the subject device (DSM Biomedical Porcine Pericardium Dental Membrane) performs similarly or equivalently to the predicate device (Bio-Gide®) across various characteristics, including in vivo performance.

The reported device performance is that the subject device achieved similar new bone formation to the predicate device in an animal model, even with faster degradation.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set (In vivo animal study): "A canine intrabony defect animal study" was performed.
  • Sample Size: Not explicitly stated as a number of animals or defects.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but it is an in vivo animal study, which is prospective by nature. The origin of the animals for the device material itself is the "United States of America."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Ground Truth for In vivo Study: The ground truth for the animal study (new bone formation) was established through "histopathology evaluations."
  • Number of Experts: Not specified.
  • Qualifications of Experts: Not specified, but implied to be pathologists or histologists capable of evaluating tissue samples for new bone formation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified. It's likely that histopathology evaluations are conducted by a single qualified expert unless discrepancies arise, at which point an internal expert consensus or review might be employed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical barrier membrane, not an AI/ML diagnostic software. The comparison was device-to-device (subject device vs. predicate device) in an animal model, not AI vs. human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Ground Truth Type: For the in vivo animal study, the ground truth for evaluating new bone formation was established by histopathology evaluations.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "characterization" and "bench tests" are akin to pre-market testing for a physical product, not machine learning model training.

9. How the ground truth for the training set was established

• Training Set Ground Truth: Not applicable, as there is no training set for an AI/ML model for this device.

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Medeor Matrix Wound Dressing is indicated for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds.

Medeor Matrix Wound Dressing is intended for one time use.

Medeor Matrix Wound Dressing, Acellular Dermal Matrix is a resorbable porcine dermisderived dressing intended for the management of topical wounds. The device is sterilized by electron beam irradiation and supplied hydrated in a double layer package. The device is a prescription device for single use only.

This document describes the Medeor Matrix Wound Dressing, a resorbable porcine dermis-derived dressing for topical wounds. However, it is a 510(k) summary for a medical device that is not an AI/ML device.

The provided document does not contain information about a study proving that an AI device meets acceptance criteria. It is a regulatory submission for a physical wound dressing and primarily focuses on demonstrating substantial equivalence to a predicate device based on its material, technological, and performance characteristics, as well as biocompatibility testing.

Therefore, I cannot fulfill the request to provide information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the provided content.

The information primarily concerns the biocompatibility and physical performance of the wound dressing, not the performance of an AI/ML algorithm.

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Meso Tendon Matrix is indicated for use in sports medicine procedures for the reinforcement and repair of soft tissue where weakness exists including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. Meso Tendon Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. Meso Tendon Matrix is supplied sterile and for one time use.

Meso Tendon Matrix is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine mesothelium tissue. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.

Here's an analysis of the acceptance criteria and supporting studies for the Meso Tendon Matrix device, based on the provided text:

This document is a 510(k) summary for a medical device (Meso Tendon Matrix) seeking substantial equivalence to a predicate device (Medeor Matrix). The acceptance criteria are primarily demonstrated through equivalence to the predicate, rather than meeting specific performance thresholds against a diagnostic "ground truth" as would be the case for a diagnostic AI device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Biocompatibility: The text does not specify the sample size for each test conducted under ISO 10993-1:2009. These typically involve standardized protocols where sample size is determined by the specific test method (e.g., number of cell cultures, animals per group).
• Biomechanical Testing: Not specified.
• Animal Implant Studies: Not specified.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing and studies conducted by DSM Biomedical or contracted testing facilities. Given the nature of these tests, it's prospective testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of device (surgical mesh) does not involve a "ground truth" established by experts in the sense of a diagnostic interpretation (e.g., radiologists reviewing images). Instead, acceptance criteria are based on objective, standardized scientific and engineering tests (biocompatibility, mechanical properties) and animal model outcomes for tissue response. The "ground truth" is established by the validated methods of these scientific tests themselves and the comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations. The "adjudication" is essentially the comparison of the test results to predefined acceptance criteria or to the predicate device's characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI or diagnostic imaging device. An MRMC study is not relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in the sense that the device's inherent properties (biocompatibility, mechanical strength, in vivo tissue response) were tested independently without a "human-in-the-loop" component. The device itself is not an algorithm, so this question is interpreted as the device's performance being evaluated in a standalone manner.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance is established through:

• Compliance with International Standards: For biocompatibility, adherence to ISO 10993-1:2009.
• Objective Engineering Measurements: For biomechanical properties (tensile strength, burst, tear, suture retention).
• Observed Biological Response: In animal implant studies, observing normal tissue healing and remodeling.
• Comparison to Predicate Device: The primary "ground truth" for regulatory clearance is substantial equivalence to the Medeor Matrix (K103787) across material, intended use, principles of operation, and technological characteristics.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set. The "training" in a broad sense would be the research and development phase where materials were selected and manufacturing processes optimized, but this is not a data-driven "model training" process.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

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Meso Bilayer Surgical Mesh is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g. hiatal, femoral, paracolostomy, umbilical.) Meso Bilayer Surgical Mesh is supplied sterile and for one time use.

Meso Bilayer Surgical Mesh is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine tissue and a synthetic absorbable polymer. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.

The provided text describes the regulatory submission for the "Meso Bilayer Surgical Mesh" and its comparison to a predicate device. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic AI device or a device with a human-in-the-loop component.

This document is a 510(k) summary for a surgical mesh, which is a medical device for tissue reinforcement. The studies mentioned (biocompatibility, biomechanical bench testing, characterization testing, and in vivo performance testing) are for evaluating the physical and biological properties of the mesh itself, showing its equivalence to a predicate device. They are not studies related to diagnostic accuracy, AI performance, or human reader effectiveness.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria are met for an AI device. The document is about a different type of medical device.

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Mesothelium Dental Membrane is indicated for: simultaneous use of GBR-membrane and implants, augmentation around implants placed in immediate extraction sockets, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

The device is intended for one time use.

Mesothelium Dental Membrane is a barrier membrane for guided tissue and bone regencration in dental applications. It is a resorbable porcine-mesothelium-derived extracellular matrix available as a lyophilized sheet. Mesothelium Dental Membrane is available in a variety of shapes and sizes. Furthermore, the device can be casily trimmed or shaped to the appropriate size to fit the defect to be treated. The device is packaged sterile in a double-layer package.

The provided text describes the regulatory clearance (510(k)) for the "Mesothelium Dental Membrane" and establishes its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML device evaluations.

The context of this document is a traditional medical device submission, focusing on material properties, intended use, and comparison to existing predicate devices. It relies on the concept of "substantial equivalence" rather than data-driven performance metrics against predefined acceptance criteria for a novel AI/ML algorithm.

Therefore, for your specific request regarding acceptance criteria and a study demonstrating performance, I must state that the provided text does not contain this information.

Here's why and what's missing:

• Acceptance Criteria & Reported Performance: The document lists "Technological Characteristics" and "Biocompatibility," "Non pyrogenic," and "Resorbable" as properties for comparison. These are characteristics, not quantitative acceptance criteria with numerical performance targets (e.g., sensitivity > X%, specificity > Y%). The "reported device performance" against such criteria is absent.
• Study Details (Sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone): None of these details are present because the submission process described here for a resorbable membrane doesn't involve the kind of performance study typical for an AI/ML diagnostic or assistive device. The "study" here is essentially the comparison table showing similar characteristics and intended use to existing devices, coupled with standard biocompatibility and material testing (which are not detailed in this summary). The ground truth for such a device would be based on established material science and biological response, not expert consensus on image interpretation or clinical outcomes of a diagnostic prediction.
• Training Set: There's no AI/ML algorithm, so there's no training set or ground truth establishment for a training set.

In summary, the provided FDA 510(k) document is for a physical medical device (a resorbable membrane) and relies on demonstrating substantial equivalence to predicate devices based on material properties and intended use. It does not present data, acceptance criteria, or study methodologies that would be relevant to evaluating an AI/ML-based medical device.

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Meso Wound Matrix is a resorbable porcine mesothelium derived product intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears), and draining wounds.

The device is intended for one time use.

Meso Wound Matrix is composed of porcine collagen from peritoneum tissue. It is an absorbent, white to off- white material supplied as sheet. The device is packaged sterile in a double-layer package.

The provided text is a 510(k) summary for the Meso Wound Matrix and an FDA letter confirming substantial equivalence. It does not present a study or acceptance criteria for device performance as typically understood for AI/software-as-a-medical-device (SaMD) products. Instead, it focuses on the device's technological characteristics, biocompatibility, and substantial equivalence to a predicate device based on regulatory requirements for a wound dressing.

Therefore, many of the requested items, such as acceptance criteria table with reported performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone performance, are not applicable or available in this document. This document is related to a traditional medical device (wound dressing), not an AI/SaMD product.

However, I can extract information relevant to the regulatory approval process as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the device's efficacy in terms of wound healing. The "performance data" section rather lists types of tests conducted for regulatory compliance.

   Acceptance Criteria Category	Reported Device Performance (Summary)
   Biocompatibility	Passed tests according to ISO 10993-1:2003
   	- Cytotoxicity
   	- Sensitization
   	- Systemic Toxicity
   	- Sub-Chronic Toxicity
   	- Genotoxicity
   	- Implantation
   	- Pyrogenicity
   	- Hemocompatibility
   Hydration	Testing conducted; no specific results or criteria provided
   Animal Testing	Testing conducted; no specific results or criteria provided
   Viral Inactivation	Testing conducted; no specific results or criteria provided
   Technological Characteristics	"Technologically identical to the cleared KN ECM Surgical Patch (K094061)"
   Material	Composed of porcine collagen from peritoneum tissue
   Sterility	Packaged sterile

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/SaMD product with a "test set" in the context of algorithm evaluation. The document mentions "animal testing" but does not specify sample sizes or provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm's performance is not relevant for this type of device submission. Regulatory decisions are based on the demonstrated characteristics and equivalence to predicate devices, assessed by FDA reviewers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the "Performance Data" sections (biocompatibility, hydration, animal, viral inactivation), the "ground truth" would be the established scientific and regulatory standards for each test type (e.g., specific endpoints for biocompatibility, histological findings in animal studies, viral load reduction for inactivation studies). No single "ground truth" like pathology or outcomes data is explicitly detailed here for a classification task. The primary ground for approval is Substantial Equivalence to a legally marketed predicate device, based on material, intended use, and technological characteristics.

8. The sample size for the training set: Not applicable. This is not an AI/ML product that uses a "training set."

9. How the ground truth for the training set was established: Not applicable. No training set is involved.

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Medeor Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications; and for reinforcement of the soft tissues, which are repaired by suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.

The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

The device is intended for single use only.

The purpose of this submission is to add hydration with autologous bodily fluids to the labeling of the Medeor Matrix device. Medeor Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues where weakness exists. The device is supplied sterile in double-layer peel-open packages. The device is packaged either dry or hydrated with saline. The device can be hydrated with saline or autologous bodily fluids prior to implantation.

Acceptance Criteria and Device Performance Study

This document describes the acceptance criteria and the study that demonstrates the Medeor™ Matrix device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

• Tensile Testing
• Suture Retention. The device passed the requirements of all tests. |
  | Hydration Testing | Not explicitly stated, but implied to allow for hydration with various fluids. | Hydration testing was performed using various hydration fluids. The device passed the requirements of all tests. |
  | In Vivo Performance | Not explicitly stated, but implied to demonstrate appropriate tissue repair and reaction in animal models. | The device was evaluated in two in vivo studies:
• Defects were repaired and evaluated in a sheep model.
• A rabbit study was performed to evaluate tissue reactions. The device passed the requirements of all tests. |
  | Substantial Equivalence | Demonstrated equivalence to predicate devices (Medeor™ Matrix (K091499) and KN ECM Surgical Patch (K094061)) in materials, intended use, and technological characteristics. | Performance Testing confirmed that Medeor Matrix is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics. |

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify exact sample sizes for each test within the performance data section. However, it indicates the following studies were conducted:

• Biocompatibility Tests: The tests were conducted "on the finished device," implying a sufficient number of samples for each specific test mandated by ISO 10993-1:2003.
• Mechanical Tests (Tensile Testing, Suture Retention): Samples of the Medeor™ Matrix were used for these tests.
• Hydration Testing: Samples were tested with "various hydration fluids."
• In Vivo Studies:
  • Sheep Model: Defects were repaired and evaluated in a sheep model. The specific number of sheep is not provided.
  • Rabbit Study: A rabbit study was performed to evaluate tissue reactions. The specific number of rabbits is not provided.

Data Provenance:
The data was generated through laboratory testing and animal studies. The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA, implying the data would be acceptable to U.S. regulatory standards. All studies appear to be prospective in nature, as they were specifically conducted to evaluate the device's performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the test set in the context of human interpretation or review. The evaluation of the device relied on standardized laboratory tests (biocompatibility, mechanical, hydration) and animal models (in vivo studies). The "ground truth" for these tests would be the established scientific and engineering principles, and the interpretation of results would be by qualified laboratory personnel and researchers, rather than a panel of clinical experts adjudicating cases.

4. Adjudication Method for the Test Set

Not applicable. The reported studies (biocompatibility, mechanical, in vivo) are objective tests with predefined pass/fail criteria based on scientific standards and observations, not on expert consensus or adjudication of subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted. This type of study typically involves human readers evaluating medical images or data, with and without AI assistance, to measure improvements in diagnostic accuracy or efficiency. The Medeor™ Matrix is a surgical mesh, not an AI-powered diagnostic device, so such a study would not be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not conducted. The Medeor™ Matrix is a physical medical device, not a software algorithm. Therefore, "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

The ground truth for the various tests was based on:

• Established Industry Standards: For biocompatibility, adherence to ISO 10993-1:2003.
• Inherent Material Properties: For mechanical testing (tensile strength, suture retention) and hydration properties, the measurements are objective.
• Biological Response: For viral inactivation and in vivo studies (sheep model for repair, rabbit study for tissue reactions), the ground truth was the observable biological outcomes and whether they met safety and performance expectations.

8. Sample Size for the Training Set

Not applicable. The Medeor™ Matrix is a physical surgical mesh and not an AI/machine learning model. Therefore, there is no "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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